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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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UNOLOK+ Luer Lock Infusion Set,21 G X ¾" ( 0.80X19MM) 7" TUBE MYCO RE-ORDER # 7001P-21L
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
21 G X ¾"
In Commercial Distribution

  • 08903347002343 ()
  • 18903347002340 ()
  • 28903347002347 ()
  • 58903347002348 ()
00234

  • Venous butterfly needle/set
UNOLOK+ Luer Lock Infusion Set,19 G X ¾" ( 1.10X19MM) 7" TUBE MYCO RE-ORDER # 7001P-19L
HINDUSTAN SYRINGES AND MEDICAL DEVICES LIMITED
19 G X ¾"
In Commercial Distribution

  • 08903347002336 ()
  • 18903347002333 ()
  • 28903347002330 ()
  • 58903347002331 ()
00233

  • Venous butterfly needle/set
PowerHeal Single Layer, 4"x 4"
Vomaris Wound Care, Inc.
4" x 4"
In Commercial Distribution

  • 00810198031577 ()

  • Length: 4 Inch
  • Width: 4 Inch
PSK-4040

  • Bioelectric wound dressing
Procellera Single Layer Rx, 5" x 5"
Vomaris Wound Care, Inc.
5" x 5"
In Commercial Distribution

  • 00894318002579 ()
  • 00810198030808 ()
  • 00810198030815 ()
VSR-0505

  • Bioelectric wound dressing
Procellera Single Layer OTC, 4"x 4"
Vomaris Wound Care, Inc.
4" x 4"
In Commercial Distribution

  • 00810198030389 ()
VSC-0404

  • Bioelectric wound dressing
Procellera Single Layer Rx 8" x 8"
Vomaris Wound Care, Inc.
8" X 8"
In Commercial Distribution

  • 00810198030327 ()
  • 00810198030303 ()
  • 00810198030334 ()
  • 00810198030341 ()
VSR-0808

  • Bioelectric wound dressing
Procellera Single Layer Rx, 4" x 8"
Vomaris Wound Care, Inc.
4" x 8"
In Commercial Distribution

  • 00810198030013 ()
  • 10810198030010 ()
VSR-0408

  • Bioelectric wound dressing
This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
4 x 0.5mL
In Commercial Distribution

  • 00812137012203 ()
  • 00812137012456 ()
502-189

  • Glycated haemoglobin (HbA1c) IVD, calibrator
For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay on automated chemistry analyzer systems. Using the Direct TIBC reagents, measurement of the total iron-binding capacity of serum occurs in a fully automated manner, without the need for any off-line separation. Since the entire reaction process is monitored by the chemistry analyzer, it is necessary to calibrate the assay with serum-based calibrators which are carried through the same reaction process as the patient specimens.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
2 x 2mL
In Commercial Distribution

  • 00812137012173 ()
  • 00812137012463 ()
502-157

  • Total iron binding capacity (TIBC) IVD, calibrator
The CRP Calibrator Set is intended to be used for the calibration of the CDS CRP Reagents. For in vitro diagnostic use only. The calibrators in this kit contain known quantities of human C-reactive protein. These reagents are to be used as calibrators with the manufacturer’s CRP Reagents.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
5 x 2mL
In Commercial Distribution

  • 00812137012142 ()
  • 00812137012432 ()
502-154

  • C-reactive protein (CRP) IVD, calibrator
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